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Comparison of Quality of Life and Changes Experienced by Patients After Epilepsy Surgery (EPICHANGE)

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ClinicalTrials.gov Identifier: NCT06035965
Recruitment Status : Recruiting
First Posted : September 13, 2023
Last Update Posted : December 18, 2023
Sponsor:
Information provided by (Responsible Party):
University Hospital, Toulouse

Study Description
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Brief Summary:

Epilepsy is one of the most common chronic neurological diseases. According to data from the World Health Organization (WHO), it affects 0.5 to 1% of the population, or around 70 million people world-wide and around 600,000 in France. There are several more or less severe forms of epilepsy depending on the type of epileptic seizures and the frequency of these seizures. About 30% of epileptic patients respond poorly to well-conducted medical treatment, which makes the number of so-called "drug-resistant" patients estimated at between 100,000 and 150,000 patients.

Epilepsy surgery is possible in some cases of drug-resistant epilepsy and can lead to complete seizure control. Beyond the impact on the control of seizures, surgery can have an impact on the lives of patients at the psychological, emotional and cognitive level, with consequences on their socio-professional but also personal life. Thus the impact on the daily life of patients after epilepsy surgery can vary greatly from one patient to another and the personal feelings of operated patients do not always seem to correspond to the objective elements collected by doctors. 2.3 The investigators want to retrospectively assess the satisfaction and quality of life of patients operated on for more than 2 years based on their epileptological results (frequency of seizures).


Condition or disease Intervention/treatment
Epilepsy Other: Epilepsy Surgery Satisfaction Questionnaire (ESSQ-19) Other: Quality of Life in Epilepsy Inventory (QOLIE-31) Other: Generalized Anxiety Disorder 7 (GAD7) Other: Neurological Disorders Depression Inventory for Epilepsy (NDDI-E) Other: Evaluation of Changes in Daily Life after Epilepsy Surgery (EVOCQUE)

Study Design
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Study Type : Observational
Estimated Enrollment : 160 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Comparison of Quality of Life and Changes Experienced by Patients After Epilepsy Surgery, With Long-term Epileptological Objective Results
Actual Study Start Date : November 30, 2023
Estimated Primary Completion Date : December 1, 2024
Estimated Study Completion Date : December 1, 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Epilepsy

Groups and Cohorts
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Intervention Details:
  • Other: Epilepsy Surgery Satisfaction Questionnaire (ESSQ-19)
    19 items assessing post-surgery satisfaction.
  • Other: Quality of Life in Epilepsy Inventory (QOLIE-31)
    31 items to assess different dimensions of quality of life
  • Other: Generalized Anxiety Disorder 7 (GAD7)
    7 items, rated from 0 to 3, to detect anxiety disorders.
  • Other: Neurological Disorders Depression Inventory for Epilepsy (NDDI-E)
    to screen for depressive disorders
  • Other: Evaluation of Changes in Daily Life after Epilepsy Surgery (EVOCQUE)
    self-questionnaire developed by the Toulouse epileptology team in 2023 for patients who have undergone epilepsy surgery. It aims to collect the feelings of patients concerning the changes induced by surgery in their daily life according to a 7-point Likert scale.

Outcome Measures
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Primary Outcome Measures :
  1. Evaluation of the changes felt by patients [ Time Frame: 2 years ]
    Evaluate the changes felt by patients more than 2 years after surgery in the context of drug-resistant epilepsy using a new questionnaire created by the epileptology team of the Toulouse University Hospital. The rating of the responses is distributed between 0 and 100 (0 = very negative change, 50 = no change and 100 = very positive change).


Eligibility Criteria
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Ages Eligible for Study:   15 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patient operated in the context of epilepsy surgery dating back more than 2 years in the epileptology center of the Toulouse University Hospital.
Criteria

Inclusion Criteria:

  • Patient operated in the context of epilepsy surgery dating back more than 2 years in the epileptology center of the Toulouse University Hospital.
  • Patient covered by a social security scheme.
  • Patient having given his non-objection to participate in the research.

Exclusion Criteria:

  • Minor under the age of 15 at the time of the questionnaires.
  • Serious psychiatric pathology unrelated to epilepsy surgery.
  • Severe intellectual disability limiting responses to self-questionnaires.
  • Language barrier.
  • Patients under guardianship and protection of justice.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06035965


Contacts
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Contact: HELENE MIRABEL 05 61 77 56 14 ext +33 mirabel.h@chu-toulouse.fr
Contact: AMAURY DE BARROS 05 61 77 90 27 ext +33 debarros.a@chu-toulouse.fr

Locations
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France
CHU de Toulouse Recruiting
Toulouse, France
Contact: HELENE MIRABEL       MIRABEL.H@CHU-TOULOUSE.FR   
Contact: AMAURY DE BARROS       debarros.a@chu-toulouse.fr   
Principal Investigator: HELENE MIRABEL         
Sub-Investigator: AMAURY DE BARROS         
Sub-Investigator: MARIE DENUELLE         
Sub-Investigator: LUC VALTON         
Sub-Investigator: JONATHAN CUROT         
Sponsors and Collaborators
University Hospital, Toulouse
Investigators
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Principal Investigator: HELENE MIRABEL University Hospital, Toulouse
More Information
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Responsible Party: University Hospital, Toulouse
ClinicalTrials.gov Identifier: NCT06035965    
Other Study ID Numbers: RC31/23/0411
First Posted: September 13, 2023    Key Record Dates
Last Update Posted: December 18, 2023
Last Verified: December 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Epilepsy
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases